Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Chamber, Oxygen, Topical, Extremity
510(k) Number K960756
Device Name LIFETECH CASSETTE
Applicant
Lifetech Systems, Inc.
11350 Random Hills Rd. #800
Fairfax,  VA  22030
Applicant Contact JOHN OBERST
Correspondent
Lifetech Systems, Inc.
11350 Random Hills Rd. #800
Fairfax,  VA  22030
Correspondent Contact JOHN OBERST
Regulation Number878.5650
Classification Product Code
KPJ  
Date Received02/23/1996
Decision Date 08/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-